Wholesale Drug Distributors in Massachusetts

Wholesale drug distributors operating in or shipping into Massachusetts must obtain a license from the Massachusetts Board of Registration in Pharmacy. This requirement applies to both resident distributors with facilities in Massachusetts and non-resident distributors shipping prescription drugs into the state for further distribution. Massachusetts enforces stringent facility, personnel, and record-keeping standards aligned with federal DSCSA requirements and NABP best practices.

The Massachusetts Board of Registration in Pharmacy (MBORP or MA Board of Pharmacy) regulates wholesale drug distribution in the state. The Board operates under statutory authority established in M.G.L. c. 112, §§ 24-42E (Massachusetts Pharmacy Practice Act), which governs pharmaceutical distribution and the Board's regulatory powers. Specific wholesale drug distributor licensing requirements are codified in M.G.L. c. 112, § 36, with implementing regulations at 247 CMR 19.00 (wholesale drug distributor regulations) and 247 CMR 21.00 (pedigree requirements and supply chain integrity). Controlled substance distribution is additionally governed by M.G.L. c. 94C (Massachusetts Controlled Substances Act).

Massachusetts requires wholesale drug distributor licenses for the following entities:

New wholesale drug distributor license applications require the following documentation:

Applicants should be prepared for a pre-licensing facility inspection by Board investigators following initial application review.

1. Pre-application consultation: Contact the Board to discuss specific requirements for your business model before formal submission.